510(k) Report

Devices descending from K062693

10 later devices reach Gladiator Bipolar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K180130ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc.20180—
+1K101670United U2 Bipolar ImplantUnited Orthopedic Corp.201051
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+2K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—